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Can Dapagliflozin Preserve Structure and Function in Transplanted Kidneys?
EU CTIS ID: 2023-510485-27-00
What this study is testing
To show that the yearly loss of renal function measured by estimated GFR from plasma creatinine concentrations over time (eGFR slope) is reduced with the SGLT2 inhibitor dapagliflozin versus placebo.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Renal transplant recipients transplanted 6 (±2) weeks earlier at OUH Rikshospitalet.
- Age 18-75 years.
- Able to comply with the medical treatment on their own.
- Calcineurin inhibitor trough concentrations in accordance with individual therapeutic range and standard dose prednisolone and mycophenolate mofetil over the last 2 weeks.
- Estimated GFR (EKFC-formula) ≥25 mL/min/1.73 m2.
You likely can't join if
- Type 1 diabetes.
- Rejection episodes of the kidney graft prior to randomization.
- Ongoing infectious disease or intermittent causes affecting renal function, e.g. untreated obstructive lymphocele.
- Malnutrition.
- Urosepsis less than 1 year prior to randomization.
- Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.
See the full eligibility criteria
- Renal transplant recipients transplanted 6 (±2) weeks earlier at OUH Rikshospitalet.
- Age 18-75 years.
- Able to comply with the medical treatment on their own.
- Calcineurin inhibitor trough concentrations in accordance with individual therapeutic range and standard dose prednisolone and mycophenolate mofetil over the last 2 weeks.
- Estimated GFR (EKFC-formula) ≥25 mL/min/1.73 m2.
- Type 1 diabetes.
- Rejection episodes of the kidney graft prior to randomization.
- Ongoing infectious disease or intermittent causes affecting renal function, e.g. untreated obstructive lymphocele.
- Malnutrition.
- Urosepsis less than 1 year prior to randomization.
- Participants with a known hypersensitivity to dapagliflozin or any of the excipients of the product.
- Women who are breastfeeding, pregnant patients or women of childbearing potential (WOCBP) not on highly effective contraception (not acceptable methods: progesterone-only oral hormonal contraception, male/female condom without spermicide or cap, diaphragm or sponge with spermicide. See also section 6.8).
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.